Active Ingredient
Dibucaine hydrochloride 0.5%
Gaayou Numbing Cream
FDA Label NDC 85248-150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Gaayou Numbing (NDC 85248-150). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anesthetic
Use
For temporary relief of local discomfort, itching, pain, soreness, or burning associated with minor skin procedure.
Warnings
For external use only.
Do Not Use
In children less than 2 year of age on open skin wounds Do not exceed the recommended daily dosage unless directed by a doctor
When Using
Avoid contact with eyes, lf this happens, rinse thoroughly with water.
Stop Use
If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician. Stop use and sek meditcal attention if signs of an alergy occur,such as rednes,irtation,sweling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medical help.
Ask Doctor
If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician. Stop use and sek meditcal attention if signs of an alergy occur,such as rednes,irtation,sweling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medical help.
Keep Oot Of Reach Of Children
Keep out of reach of children
Directions
Before applying the numbing cream,make sure to wash your hands thoroughly and put on disposable procedure gloves.
Clean the area of the body receivina the procedure,Dry completely.
Apply a generous amount of numbing cream to the cleaned area and rub it in thoroughly in a circlar motion for 30 to 60 seconds,Then. cover with plastic wrap.
Leave the cream and wrap in place for 30 to 45 minutes,Wipe away the cream and thoroughly clean the area to prepare for the upcoming procedure.
Other Information
Store between 15-30℃(59-86F). Avoid freezing and excessive heat above 40 ℃(104°F).
Inactive Ingredients
Purifed Water,Thymol,tween,Carbomeralcohol,azone.
Principal Display Panel
0.5 (2761b42de6da6a031525c8c0edbf8e5f)
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